The TN20 (Oral Insulin) Phase-II Clinical Trial Completes Enrollment
TN20 is the name of a specific oral insulin clinical trial, which completed enrollment in March 2017. Since this study will follow people for one year, they should finish collecting data in March 2018.
The following blog post:
covers oral insulin in detail, describing why people think it might prevent type-1 diabetes, and the other clinical trials (and there are several) currently running.
Clinical Trial Registery: https://clinicaltrials.gov/ct2/show/NCT02580877
T-Rex Study Is Half Enrolled
I've previously blogged on the T-Rex study (sometimes under the name "Polyclonal T-Regs"):
It is currently in a phase-II clinical trial, and that trial is now half enrolled (56 people out of 111).
This study is unusual in that it can enroll kids as young as 8, and is recruiting people at over a dozen different sites in the US: https://clinicaltrials.gov/ct2/show/study/NCT02691247#contacts
A quick summary of this treatment is as follows: remove one specific type of T regulator cell (called "CD4(+)CD25(+)CD127(lo)") from a person with type-1 diabetes. Grow them out so you have about 500 times more, and then put them back in the same person. Since regulatory T cells naturally regulate the body's immune system, and the patient now has more of them, the hope is that they will prevent the autoimmune attack which causes type-1 diabetes.
Results from the previous phase-I trial found that this treatment preserved beta cells. C-peptide levels remained constant in the treated group. Since C-peptide levels drop during the honeymoon period, these treated people did better than untreated people would be expected to do. The previous phase-I study did not have a control group, but the current phase-II study does.
Results of Phase-I Clinical Trial of REMD-477 for T1D
I probably will not cover this moving forward, because it is more treatment than cure. REMD-477 is a Glucagon Receptor Antibody. The hope is that giving this to people with type-1 will cause them to produce less glucagon and therefore use less insulin. This was a 21 person trial, where half the people got the treatment and half did not. The people spend a few days in a hospital, and then were followed for a few weeks "in the wild".
They found that glucagon levels did go down (20-30%), insulin requirements did go down (about 10%), and people did spend more time in their target BG range (about 15%), for a few weeks after treatment.
Several Press Releases: http://sashayan.edicy.co/new-media
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT02715193
They have started a follow up study, which will enroll 75 people and last 24 weeks. They hope to finish it in Sept-2018: https://clinicaltrials.gov/ct2/show/NCT03117998
I suspect that any treatment which lowers glucagon levels is going to have some impact on people who play sports, and anyone who has an unexpected low (especially if they need a Glucagon injection, but even if not). This study did not address either of those issues, but I suspect that follow on studies will need to, if they want FDA approval for this as a treatment for type-1 diabetes.
Diamyd Unsuccessful in Phase-II Clinical Trial on Presymptomatics
This study is another testament to the optimism of researchers. Diamyd ("GAD Vaccine") has been tested for over 10 years. None of these trials has been particularly successful. They culminated in an unsuccessful Phase-III trial years ago. You can read my previous blogging on Diamyd here:
However, researchers are natural optimists. And it is important that they are. Society needs optimistic researchers so that they will repeatedly attack problems, and not give up, even in the face of adversity. Previous Diamyd trials had been done on honeymooners, so this trial was done on presymptomatics. Unfortunately it failed.
News Coverage: http://www.diabetesincontrol.com/ada-alum-gad-diamyd-vaccine-fails-to-prevent-type-1-diabetes
Press Release: http://www.diabetes.org/newsroom/press-releases/2017/larsson-scientific-sessions-2017.html
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT01122446
This trial reminded me that, in the world of type-1 diabetes, if the headline reads "new treatment shown safe" that really means "new treatment is not effective". Almost all clinical trials aimed at type-1 diabetes measure both safety and effectiveness. This is especially true of phase-II trials, like this one, and phase-III trials. Since effectiveness data is obviously more news worthy than safety data, if the headline talks about safety, that means the treatment was ineffective.
The headline for the press release above is classic that way "Autoantigen GAD-Vaccine is Safe for Children at High Risk for Developing Type 1 Diabetes", while the headline for the news coverage is much more accurate "ADA: Alum-GAD (Diamyd) Vaccine Fails to Prevent Type 1 Diabetes".
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All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.